BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITINOL COMPRESSION STAPLE, 9W X 7L

    MDR report key: 23535312 · Received November 12, 2025

    Report

    Report Number
    1220246-2025-05053
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    April 15, 2025
    Report Date
    November 12, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    JDR
    UDI-DI
    00888867287853
    PMA / PMN Number
    K203180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN INITIAL HALLUX VALGUS SURGERY WITH AN ARTHREX DYNANITE STAPLE THE PATIENT STILL HAS PAIN IN THE IMPLANT AREA. NO NOTICEABLE SWELLING OR REDNESS HAS OCCURRED. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2544145 NITINOL COMPRESSION STAPLE, 9W X 7L STAPLE, FIXATION, BONE JDR ARTHREX, INC. NITINOL COMPRESSION STAPLE, 9W X 7L 3212133781 00888867287853

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other